Trial Information

SWOG S0931 Phase III Randomized Study of Everolimus Versus Placebo in Patients With Renal Cell Carcinoma Who Have Undergone Nephrectomy or Partial Nephrectomy

To compare recurrence-free survival in renal carcinoma patients randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy.

Patient Inclusion Criteria:

Histologically or cytologically confirmed renal cell carcinoma
Clear cell or non-clear cell allowed
No disease of the collecting duct or medullary carcinoma
Considered pathologically either intermediate high-risk or very high-risk disease
No history of distant metastases
Patients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are eligible
Have undergone a full surgical resection (radical nephrectomy or partial nephrectomy) including removal of all clinically positive nodes
Surgical margins must be negative
Patients with positive renal vein margins are eligible unless there is invasion of the renal vein wall at the margin (provided no other margins are positive)
Patients must be registered within 84 days after the date of the first surgical resection of the first tumor
No evidence of residual or metastatic renal cell cancer on CT scan of the chest, abdomen, and pelvis (all with oral and IV contrast) performed after nephrectomy and within 28 days before registration

Patient Exclusion Criteria:

Surgical margins must be negative
Zubrod performance status 0-1
Not pregnant or nursing
Fertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment
Able to take oral medications
Patients must not have any of the following:
1. NYHA class III-IV cardiac disease (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort)
2. Unstable angina pectoris
3. Myocardial infarction within the past 6 months
4. Serious uncontrolled cardiac arrhythmia

Patients must NOT have liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C)
HBV and HCV testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection
Must be able to take oral medications
No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
No known history of HIV seropositivity
No known uncontrolled, underlying pulmonary disease (spirometry and DLCO ≤ 50% of predicted OR oxygen saturation ≤ 88% at rest on room air)
No uncontrolled hyperlipidemia (fasting serum cholesterol > 300 mg/dL AND fasting triglycerides > 2.5 times ULN) obtained within 28 days prior to registration
Optimal lipid control must be achieved before registration and monitored during protocol treatment
No uncontrolled diabetes mellitus (defined by fasting serum glucose > 1.5 times ULN) obtained within 28 days prior to registration.
Optimal glucose control must be achieved before registration and monitored during protocol treatment
No prior malignancies except for any of the following:
1. Adequately treated basal cell or squamous cell skin cancer
2. In situ cervical cancer
3. Adequately treated stage I or stage II cancer from which the patient is currently in complete remission
4. Any other cancer from which the patient has been disease-free for 5 years

No known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to their excipients
No contraindications to receiving either IV iodine-based contrast or gadolinium

Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071
Email: janeen.bazan@shermanhospital.org

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Research Center Information: Sherman Health

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